BioWaveGO RX

K210202 · Biowave Corporation · GZJ · Feb 24, 2021 · Neurology

Device Facts

• Record ID: K210202
• Device Name: BioWaveGO RX
• Applicant: Biowave Corporation
• Product Code: GZJ · Neurology
• Decision Date: Feb 24, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioWaveGO Rx is indicated for prescription use for: · Symptomatic relief of chronic, intractable pain · Symptomatic relief of acute pain · As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

Device Story

BioWaveGO Rx is a battery-powered transcutaneous electrical nerve stimulator (TENS) for pain relief. Device delivers high-frequency alternating current sinusoidal signals via electrodes to skin. Principle of operation involves biphasic, continuous modulation waveform (sum of two sine waves) to provide symptomatic relief. Device is identical in design, battery, and software to previously cleared BioWaveGO (K180943). Operated by patient under prescription; includes smartphone interface and Bluetooth connectivity. Healthcare provider prescribes device; patient applies electrodes and manages therapy sessions. Output affects clinical decision-making by providing non-pharmacological pain management. Benefits include symptomatic relief of acute and chronic pain conditions.

Clinical Evidence

Bench testing only. No clinical data presented. Substantial equivalence established through identical design, materials, and performance specifications compared to the predicate device.

Technological Characteristics

Battery-powered (3.2V 1100mAh lithium iron phosphate) TENS device. Housing: ABS plastic via injection molding. Waveform: Biphasic, sum of two sine waves (4062 Hz + 3940 Hz). Output: Regulated voltage, 30-minute timer. Connectivity: Bluetooth, smartphone interface. Safety: Software-controlled automatic overload/no-load trip, automatic shut-off, patient override. Sterilization: Not applicable (non-sterile device).

Indications for Use

Indicated for prescription use for symptomatic relief of chronic, intractable pain; symptomatic relief of acute pain; and as adjunctive treatment for post-surgical and post-traumatic acute pain.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• BioWaveGO (K180943)

Reference Devices

• BioWaveHOME (K152437)

Submission Summary (Full Text)

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February 24, 2021

BioWave Corporation % Dave Mcgurl Director, Regulatory Affairs Mcra LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001

Re: K210202

Trade/Device Name: BioWaveGO RX Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: January 12, 2021 Received: January 25, 2021

Dear Dave Mcgurl:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210202

Device Name BioWaveGO Rx

Indications for Use (Describe)

The BioWaveGO Rx is indicated for prescription use for:

· Symptomatic relief of chronic, intractable pain

· Symptomatic relief of acute pain

· As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| Device Trade Name: | BioWaveGO Rx System |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | BioWave Corporation<br>8 Knight Street, Suite 201<br>Norwalk, CT 06851 |
| Contact: | Bradford Siff<br>Founder & President<br>BioWave Corporation<br>8 Knight Street, Suite 201<br>Norwalk, CT 06851<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Prepared by: | Mr. Dave McGurl<br>Director, Regulatory Affairs<br>MCRA, LLC<br>1050 K Street NW, Suite 1000<br>Washington, DC 20001<br>Office: 202.552.5797<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | February 24, 2021 |
| Regulation Number: | 21 CFR §882.5890 |
| Regulation Name: | Transcutaneous Electrical Nerve Stimulator For Pain Relief |
| Regulatory Class: | II |
| Product Code: | GZJ |

### Indications for Use:

The BioWaveGO Rx is indicated for prescription use for:

- · Symptomatic relief of chronic, intractable pain
- Symptomatic relief of acute pain
- · As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

### Device Description:

The BioWaveGO Rx Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain relief based on the technology of parent devices BioWaveHOME.

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The BioWaveGO Rx device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain. The device is identical in design to the BioWaveGO cleared in K180943. However, this 510(k) seeks clearance of the device for prescription use. The BioWaveGO Rx has the identical battery and software to the original clearance in K180943.

#### Predicate Device:

BioWave Corporation's BioWaveGO Neuromodulation Pain Therapy Device is substantially equivalent to the predicates previously cleared with respect to indications, design, function, and materials, as outlined below.

| Manufacturer | Device Name | K-Number |
|---------------------|-------------|-----------------------------|
| BioWave Corporation | BioWaveGO | K180943 (primary predicate) |
| BioWave Corporation | BioWaveHOME | K152437 (reference device) |

### Performance Testing Summary:

No additional testing was required for this Special 510(k).

### Substantial Equivalence:

The subject device, the BioWaveGO Rx, was demonstrated to be substantially equivalent to the primary predicate device cited in the table above with respect to indications, design, materials, function, manufacturing, and/or performance and to the predicate devices with respect to availability (i.e. prescription) and indications. The subject device is identical in indications and design. The only difference is to make the device available as a prescription use device. There is no additional risk as a healthcare professional would be prescribing the device to the patient.

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| Predicate Comparison Table | | | | |
|--------------------------------------|---------------------------------------|--------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| | Subject Device<br>BioWaveGO Rx Device | Primary Predicate Device<br>BioWaveGO OTC Device | Reference Device<br>BioWaveHOME Device | Comparison |
| Manufacturer | BioWave Corporation | BioWave Corporation | BioWave Corporation | - |
| Trade Name | BioWaveGO Rx | BioWaveGO | BioWaveHOME | - |
| 510(k) | K210202 (subject) | K180943 | K152437 | Identical. Both the primary<br>predicate and subject device<br>have Bluetooth. |
| Bluetooth Capable | Yes | Yes | No | Identical. Both the primary<br>predicate and subject device<br>have Bluetooth. |
| Smartphone Interface | Yes | Yes | No | Identical. Both the primary<br>predicate and subject device<br>have a smart phone interface. |
| Prescription or Over-the-<br>Counter | Prescription | Over-the-Counter | Prescription | Similar. The primary predicate<br>is for OTC use. The reference<br>and subject devices are for<br>prescription use. |
| Image | Image: BioWaveGO | Image: BioWaveGO | Image: BioWaveHOME | - |

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| | Subject Device<br>BioWaveGO Rx Device | Primary Predicate Device<br>BioWaveGO OTC Device | Reference Device<br>BioWaveHOME Device | Comparison |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| | The BioWaveGO Rx<br>Neuromodulation Pain<br>Therapy Device is indicated<br>for prescription use for: | The BioWaveGO<br>Neuromodulation Pain Therapy<br>Device is indicated for over-the-<br>counter use for: | The BioWaveHOME<br>Neuromodulation Pain Therapy<br>Device is indicated for<br>prescription use for: | |
| Indications | - Symptomatic relief of<br>chronic, intractable pain<br>- Symptomatic relief of acute<br>pain<br>- As an adjunctive treatment in<br>the management of post-<br>surgical and post-traumatic<br>acute pain | - Symptomatic relief of chronic,<br>intractable pain<br>- Symptomatic relief of acute<br>pain<br>- As an adjunctive treatment<br>in the management of post-<br>surgical and post-traumatic<br>acute pain | - Symptomatic relief of<br>chronic, intractable pain, post-<br>surgical, and post-traumatic<br>acute pain<br>- Symptomatic relief of acute<br>pain<br>- Symptomatic relief of post-<br>operative pain | Identical. The indications for<br>use are the same as the<br>primary predicate. |

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| Device Name, Model | BioWave Corporation<br>BioWaveGO RX Device<br>(Subject) | BioWave Corporation<br>BioWaveGO Device (K180943) | BioWave Corporation<br>BioWaveHOME Device<br>(K152437) | Comparison |
|----------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------|
| | BioWaveGO Rx | BioWaveGO | BioWaveHOME | - |
| Manufacturer | BioWave Corporation | BioWave Corporation | BioWave Corporation | - |
| Power Source(s) | one 3.2V 1100mAh rechargeable<br>lithium iron phosphate battery | one 3.2V 1100mAh rechargeable<br>lithium iron phosphate battery | two 3.2V 3300mAh<br>rechargeable lithium iron<br>phosphate batteries | Identical<br>(BioWaveGO only) |
| Method of Line Current Isolation | Battery + interlocks | Battery + interlocks | Battery + interlocks | Identical |
| Patient Leakage Current | None | None | None | Identical |
| Normal condition | None | None | None | Identical |
| Single fault condition | None | None | None | Identical |
| Number of Output Modes | One | One | One | Identical |
| Number of Output Channels | One | One | One | Identical |
| Synchronous or Alternating? | N/A | N/A | N/A | - |
| Method of Channel Isolation | N/A | N/A | N/A | - |
| Regulated Current or Regulated<br>Voltage? | Regulated Voltage | Regulated Voltage | Regulated Voltage | Identical |
| Software/Firmware/Microprocessor<br>Control? | Yes | Yes | Yes | Identical |
| Automatic Overload Trip? | Yes (software) | Yes (software) | Yes (software) | Identical |
| Automatic No-Load Trip? | Yes (software) | Yes (software) | Yes (software) | Identical |
| Automatic Shut Off? | Yes | Yes | Yes | Identical |
| Patient Override Control? | Yes | Yes | Yes | Identical |
| Indicator Display: | Yes | Yes | Yes | Identical |
| On/Off Status? | Yes | Yes | Yes | Identical |
| Low Battery? | Yes | Yes | Yes | Identical |
| Voltage/Current Level? | Yes (% of full scale) | Yes (% of full scale) | Yes (% of full scale) | Identical |
| Timer Range - (minutes) | 30 | 30 | 30 | Identical |
| Compliance with Voluntary<br>Standards? | Yes | Yes | Yes | Identical |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Identical |
| Weight | 6 ounces | 6 ounces | 1.0 lbs | Identical<br>(BioWaveGO only) |
| | BioWave Corporation<br>BioWaveGO RX Device<br>(Subject) | BioWave Corporation<br>BioWaveGO Device (K180943) | BioWave Corporation<br>BioWaveHOME Device<br>(K152437) | Comparison |
| Dimensions (in.) (W x H x D) | 3.0" x"4.0" x 1.0" | 3.0" x"4.0" x 1.0" | 3.75" x 6.0" x 1.75" | Identical<br>(BioWaveGO only) |
| Housing Materials and Construction | ABS via conventional injection<br>molding | ABS via conventional injection<br>molding | ABS via conventional<br>injection molding | Identical |

#### Comparison of Basic Unit Characteristics for BioWayeHOME (K152437) and RioWayeGO (K180943)

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#### Comparison of Output Specifications for BioWaveGO Rx to BioWaveHOME (K152437) and BioWaveGO (K180943)

| | BioWave Corporation<br>BioWaveGO Rx Device<br>(Subject) | BioWave Corporation<br>BioWaveGO Device<br>(K180943) | Parent BioWave Corporation<br>BioWaveHOME Device<br>(K152437) | Comparison |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Waveform | Biphasic | Biphasic | Biphasic | Identical |
| Shape | Sum of 2 sine waves | Sum of 2 sine waves | Sum of 2 sine waves | Identical |
| Maximum Output Voltage Available<br>(+1-2%) (with software calibration<br>correction) | 80V p-p @ 500 Ω<br>20 V AC RMS | 80V p-p @ 500 Ω<br>20 V AC RMS | 110V p-p @ 500 Ω<br>27.5 V AC RMS | Identical<br>(BioWaveGO only)<br>BioWaveGO Rx offers a<br>decreased maximum<br>voltage compared to<br>BioWaveHOME |
| Maximum Output Current (+1- 2<br>%) (current depends on load) | 160mA p-p @ 500 Ω<br>40mA RMS<br>40 mA p-p @ 2kΩ<br>Trip out @ 10kΩ | 160mA p-p @ 500 Ω<br>40mA RMS<br>40 mA p-p @ 2kΩ<br>Trip out @ 10kΩ | 220mA p-p @ 500 Ω<br>55mA RMS<br>55 mA p-p @ 2kΩ<br>Trip out @ 10kΩ | Identical<br>(BioWaveGO only)<br>BioWaveGO Rx has a<br>lower maximum current<br>density compared to<br>BioWaveHOME. |
| Pulse Width | Continuous modulation | Continuous modulation | Continuous modulation | Identical |
| Frequency (Hz) | 4062 Hz + 3940 Hz | 4062 Hz + 3940 Hz | 3980 Hz + 3858 Hz | Equivalence based on<br>frequency difference |
| For interferential modes only:<br>- Beat Frequency (Hz) | 122 Hz | 122 Hz | 122 Hz | Identical |
| For multiphasic waveforms only:<br>- Symmetrical phases?<br>- Phase Duration | N/A<br>N/A | N/A<br>N/A | N/A<br>N/A | - |

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| | BioWave Corporation<br>BioWaveGO Rx Device<br>(Subject) | BioWave Corporation<br>BioWaveGO Device<br>(K180943) | Parent BioWave Corporation<br>BioWaveHOME Device<br>(K152437) | Comparison |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Net Charge (m C per pulse) (If zero,<br>state method of achieving zero net<br>charge.) | 0 @ 500 Ω<br>biphasic - AC coupled<br>continuous wave | 0 @ 500 Ω<br>biphasic - AC coupled<br>continuous wave | 0 @ 500 Ω<br>biphasic - AC coupled<br>continuous wave | Identical |
| Maximum Phase Charge, (μ C) | N/A | N/A | N/A | - |
| Maximum Current Density,<br>(µmA/cm²)<br>(with 1.375" diam pad = 9.58 cm2<br>area) | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | Identical |
| Maximum Power Density, (W/cm²)<br>(using 1.375" diam 9.58 cm² electrode<br>conductive surface area) | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | Identical |
| Burst Mode<br>a. Pulses per burst<br>b. Bursts per second<br>c. Burst duration (seconds)<br>d. Duty Cycle [Line (b) x Line (c)] | N/A | N/A | N/A | - |
| ON Time (seconds) | N/A | N/A | N/A | - |
| OFF Time (seconds) | N/A | N/A | N/A | - |
| Additional Features (if applicable) | Many safety interlocks: cable<br>connected to unit, pads<br>connected to cable, pads<br>connected to body, max power<br>density, battery ok for<br>treatment, charger connected<br>(trip off) | Many safety interlocks: cable<br>connected to unit, pads<br>connected to cable, pads<br>connected to body, max power<br>density, battery ok for<br>treatment, charger connected<br>(trip off) | Many safety interlocks: cable<br>connected to unit, pads<br>connected to cable, pads<br>connected to body, max power<br>density, battery ok for treatment,<br>charger connected (trip off) | Identical |

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### Conclusion:

The BioWaveGO Rx device has been found to be substantially equivalent to the previously cleared predicate device, BioWaveGO, with respect to its intended use, design, function, materials, and performance.